Trial record 8 of 12 for:    Open Studies | "Arthritis, Infectious"

Ultrasonography Assessment of Mono Septic Arthritis on Native Joint (SEPT'ECHO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02018952
First received: December 11, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The aim of this trial is to study the interest of ultrasonography among patients with mono septic arthritis.

Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.

Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.

Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.

However, MRI is expensive and not rapidly accessible.

Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.

The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the mono septic arthritis evolution and prognosis.

The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.


Condition Intervention
Mono Septic Arthritis
Other: Ultrasonography assessment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Ultrasonography Assessment of Mono Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Abnormalities joint structure influencing the mono septic arthritis evolution and prognosis [ Time Frame: 15 months ] [ Designated as safety issue: No ]

    Ultrasonography description of :

    • synovium aspect : homogeneous, nodular
    • maximum thickness synovium
    • synovium doppler signal (grade 0, 1, 2, 3)
    • presence and aspect of joint effusion : anechoic, hypo/hyperechoic, heterogeneous
    • presence and aspect of bone erosions : single, minimal/deep, multiple, minimal/ deep
    • presence of a synovium partitioning
    • soft tissue aspect : cellulitis, myelitis


Secondary Outcome Measures:
  • The evolution of the abnormalities joint structure using ultrasonography [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : ultrasonography parameters at day 0, Day 4, Day 15, and 3 months.

  • Return delay apyrexia [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Return delay apyrexia.

  • Delay of surgical management [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Delay of surgical management.

  • Normalization of C Reactive Protein levels [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Normalization of C Reactive Protein levels.

  • Measure of range of motion at 3 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Percentage of decreased range of motion relative to normal range of motion at 3 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Pain at rest measured by scale at 3 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Pain during activity measured by scale at 3 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Functional outcome score Short Form (SF) 36 at 3 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ultrasonography assessment Other: Ultrasonography assessment

All patients will be seen at day 0, day 4, day 15 and at 3 months. These visits are usually programmed. Only monitoring ultrasonography, a non invasive exam, and self-administered questionnaires will be made, additional to standard exams for all patients included (no control group).

Day 0 :

  • Information of patient and no opposition getting
  • Clinical exam
  • Laboratory tests
  • Radiography of the targeted joint
  • Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)

Day 4 :

  • Clinical exam
  • Laboratory tests
  • Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)

Day15 :

  • Clinical exam
  • Laboratory tests
  • Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)

M3 :

  • Clinical exam
  • Laboratory tests
  • Radiography of the targeted joint
  • Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
  • Functional outcome

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes and of La Roche sur Yon) with a mono septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.

Exclusion Criteria:

  • Presence of material on the targeted joint
  • Oligo arthritis
  • Endocarditis
  • Age < 18 years old
  • Patients under guardianship
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018952

Contacts
Contact: Benoît LE GOFF, Doctor 02 40 08 48 24 benoit.legoff@chu-nantes.fr

Locations
France
CH de Nantes Recruiting
Nantes, France, 44093
Contact: Benoît LE GOFF, Doctor    02 40 08 48 24    benoit.legoff@chu-nantes.fr   
Principal Investigator: Benoît LE GOFF, Doctor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Benoît LE GOFF, Doctor CHU de Nantes
Study Chair: Grégoire CORMIER, Doctor CHD La Roche-sur-Yon
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02018952     History of Changes
Other Study ID Numbers: RC13_0393
Study First Received: December 11, 2013
Last Updated: May 28, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Nantes University Hospital:
Septic arthritis
Ultrasonography
Prognosis parameters

Additional relevant MeSH terms:
Arthritis
Arthritis, Infectious
Joint Diseases
Musculoskeletal Diseases
Infection

ClinicalTrials.gov processed this record on July 20, 2014